Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Leland Stanford Junior University
Stanford, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Kansas City Cancer Center
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
Time frame: throughout the study, or for a maximum of 2 years
Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))
Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.
Time frame: throughout the study, or for a maximum of 2 years
Time to Progression
Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.
Time frame: throughout the study, or for a maximum of 2 years
Time to Response
Time to response was defined as the interval between the first date of treatment and the first notation of response.
Time frame: throughout the study, or for a maximum of 2 years
Duration of Response
Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.
Time frame: throughout the study, or for a maximum of 2 years
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